A Study to Evaluate Different Dose Levels of Ad26.COV2.S in Healthy Adolescents From 12 to 17 Years Inclusive

Phase 2 Completed 304 enrolled Janssen Vaccines & Prevention B.V.

RandomizedParallel-groupDouble-blindPrevention

Summary

The primary purpose of this study is to assess the safety, reactogenicity, and humoral immune response of Ad26.COV2.S administered intramuscularly (IM) as a 1-dose schedule or as a 2-dose schedule (56-day interval) in adolescents.

Timeline

Start: 2021-09-27
Primary completion: 2023-08-14
Completion: 2023-08-14

Publications

Tica J, Rezelj VV, Baron B, van Paassen V, Zaidman J, Fairlie L, Scheper G, Le Gars M, Struyf F, Douoguih M, Ruiz-Guinazu J; COV3006 study group; COV3006 Study Group Collaborators. Safety and immunogenicity of Ad26.COV2.S in adolescents: Phase 2 randomized clinical trial. Hum Vaccin Immunother. 2025 Dec;21(1):2450120. doi: 10.1080/21645515.2025.2450120. Epub 2025 Jan 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ad26.COV2.S	Vaccine	6.25e+09 unknown	Intramuscular
Subject	Ad26.COV2.S	Vaccine	1.25e+10 unknown	Intramuscular
Subject	Ad26.COV2.S	Vaccine	2.5e+10 unknown	Intramuscular

A Study to Evaluate Different Dose Levels of Ad26.COV2.S in Healthy Adolescents From 12 to 17 Years Inclusive

Summary

Timeline

Publications

Drugs

Indications